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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADJUSTING DEVICE TIBIA T2 ALPHA TIBIA ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL ADJUSTING DEVICE TIBIA T2 ALPHA TIBIA ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 2353-4105
Device Problem Unstable (1667)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2021
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported: "during surgery the adjusting device (2353-4105) can wriggle at the targeting arm (2353-4106). It turns out that a "pin/split" has fallen out of the adjusting device and therefore the feature of "locking" the adjusting device in the targeting arm, is not possible. ".
 
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Brand NameADJUSTING DEVICE TIBIA T2 ALPHA TIBIA
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
kristen canter
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11382060
MDR Text Key233716890
Report Number0009610622-2021-00308
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K193308
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2353-4105
Device Catalogue Number23534105
Device Lot NumberKME913779
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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